EncephalitisNeuroSARSNCT04460599
Neurological Features During COVID19
An observational study of Encephalitis, run by Centre d'Investigation Clinique et Technologique 805 at 1 site in France.
Trial summary
Description of the neurological impairment: clinico-radiological and electrophysilogical correlations Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Encephalitis
- What is being tested?
- Observation
- How many people
- 30 participants
- Where
- 1 siteFrance
- Study dates
- 8 Mar 2020to 30 Sep 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Adult, Older adult
Study population: Population hospitalized in ICU for COVID 19.
Who may be able to join
- PCR SARS COV2 positive or CT Scan
- Central neurological signs such as confusion, epilepsy, abnormal movement, pyramidal signs, motor or sensory deficit, involvement of cranial pairs (such as anomie or ageusia) or peripheral.
- Dysautonomic signs such as hypotension or hypertension, bradycardia or tachycardia, hypothermia, SIADH not explained by therapy or a pathology other than SARS COV 2 infection
Who cannot join
- Contraindication to performing an MRI scan
- Minor
- Pregnant woman
- No follow-up possible at 6 months
Trial locations and contacts
1 site in 1 country.
Isabelle Bossard contact
France1 site, 1 recruiting
- Recruiting
Hopital Raymond Poincare
Garches, 92380
DAVID ORLIKOWSKI, MD PHD, (33)147107777, david.orlikowski@rpc.aphp.fr
(33)147104469
About this study
Official title: Description of neurolOgical Involvement Observed During SARS COV2 Infection
Description of the neurological impairment: clinico-radiological and electrophysilogical correlations
Read the detailed description
Describe short and long term clinical radiological and electrophysilogical presentations of neurological damage central and peripheral SARS COV2 infection Describe the association between neurological, respiratory and dysautonomic Determine the prognosis of neurological damages to short and long term.
- Conditions
- Encephalitis
- Being tested
- Observation
- Keywords
- Cranial nerves, brainstem, dysautonomia
- Medical subject headings
- Encephalitis, Autonomic Nervous System Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ObservationOther
Observation of recorded neurological signs
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary
incidence of objective neurological damage
Measured: 6 months
Secondary outcomes (1)
Secondary
incidence of clinical neurological damage incidence of radiological neurological damage incidence of neurophysiological neurological damage
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jul 2020
- Study start8 Mar 2020
- Primary completion30 Jul 2020 (estimated)
- Study completion30 Sep 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for EncephalitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre d'Investigation Clinique et Technologique 805
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, david orlikowski, Centre d'Investigation Clinique et Technologique 805
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04460599
- Sponsor's protocol ID
- Brain COVID
- Acronym
- NeuroSARS
- Status last verified
- Jul 2020
- First submitted
- 6 Jul 2020
- Last updated
- 9 Jul 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Description of neurolOgical Involvement Observed During SARS COV2 Infection
- ClinicalTrials.gov ID
- NCT04460599
- Acronym / sponsor ID
- NeuroSARS / Brain COVID
- Conditions
- Encephalitis
- Keywords
- Cranial nerves, brainstem, dysautonomia
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Centre d'Investigation Clinique et Technologique 805University, hospital or other
- Study start
- 8 Mar 2020 (actual)
- Primary completion
- 30 Jul 2020 (estimated)
- Study completion
- 30 Sep 2020 (estimated)
- First posted
- 7 Jul 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Description of the neurological impairment: clinico-radiological and electrophysilogical correlations
Detailed description
Describe short and long term clinical radiological and electrophysilogical presentations of neurological damage central and peripheral SARS COV2 infection Describe the association between neurological, respiratory and dysautonomic Determine the prognosis of neurological damages to short and long term.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Population hospitalized in ICU for COVID 19.
Key inclusion criteria (3 listed)
- PCR SARS COV2 positive or CT Scan
- Central neurological signs such as confusion, epilepsy, abnormal movement, pyramidal signs, motor or sensory deficit, involvement of cranial pairs (such as anomie or ageusia) or peripheral.
- Dysautonomic signs such as hypotension or hypertension, bradycardia or tachycardia, hypothermia, SIADH not explained by therapy or a pathology other than SARS COV 2 infection
Key exclusion criteria (4 listed)
- Contraindication to performing an MRI scan
- Minor
- Pregnant woman
- No follow-up possible at 6 months
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ObservationObservation of recorded neurological signs | Other | – |
Primary outcome
Primary
Time frame: 6 months
incidence of objective neurological damage
1 secondary outcome
Secondary
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jul 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Isabelle Bossard contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Encephalitis, run by Centre d'Investigation Clinique et Technologique 805 at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 9 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact David Orlikowski, MD PhD (0147107777, david.orlikowski@aphp.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Primary (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jul 2020.